This guidance document provides recommendations to industry, systems and service providers,consultants, FDA staff, and others regarding premarket notification (510(k)) submissions for computer-assisted detection (CADe) devices applied to radiology images and radiology device data (often referred to as “radiological data” in this document). CADe devices are computerized systems that incorporate pattern recognition and data analysis capabilities (i.e., combine values, measurements, or features extracted from the patient radiological data) and are intended to identify, mark, highlight, or in any other manner direct attention to portions of an image, or aspects of radiology device data, that may reveal abnormalities during interpretation of patient radiology images or patient radiology device data by the intended user (i.e., a physician or other health care professional), referred to as the “clinician” in this document. We have considered the recommendations on documentation and performance testing for CADe devices made during the Radiology Devices Panel meetings on March 4-5, 2008 and November 17-18, 2009. We have also considered the public comments received on the draft guidance announced in the Federal Register on October 21, 2009 (74 FR 54053).

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance documents means that something is suggested or recommended, but not required.